Monthly Archives: January 2016

This is part 3 in our series examining foreign filing restrictions and licenses in the U.S. and in a number of countries throughout the world. To view part 1, foreign filing restrictions and licenses in the U.S., click here. To view part 2, foreign filing restrictions and licenses in the China, click here.

Foreign filing licenses in India

There are a myriad of reasons an Applicant (such as an entity or individual filing a patent application) may wish to obtain a foreign filing license to first file a patent application abroad rather than directly in India. These include:
• A desire to cater to foreign markets outside of India;
• The subject matter of patent application has no or low market potential in India;
• The subject matter of patent application is considered to be non-patentable subject matter in India; and/or
• There are research and development teams across countries are working together

Obtaining a foreign filing license in India provides an Applicant with the requisite permission to file a patent application outside of India. The specifics involved in this process are described below.

The Indian Patent Office rules are unique in that the requirement for obtaining a foreign filing license is not necessarily based on the place of invention, but the resident status of the inventor. What constitutes “resident” status in India is also discussed in more detail herein.

If a person is considered to be resident in India, then a foreign filing license is needed in the cases of filing a patent application directly in a foreign country less than 6 weeks from filing the application in India or without a direct filing in India. Examples of specific cases requiring a foreign filing license include:
• Filing patent application directly in a foreign country, without first filing in India
• Filing international patent application under the Patent Cooperation Treaty (PCT) in a country other than India, without first filing in India
• Filing patent application directly in a foreign country, less than 6 weeks from filing in India
• Filing patent application under the PCT in a foreign country other than India, less than 6 weeks from filing in India

What are the Indian Foreign Filing Restrictions?

Similar to other countries, the procedure for obtaining a foreign filing license in India is designed with the intention of allowing the Indian government to monitor inventions, especially the inventions that relate to defense/atomic energy and those that are relevant to national interests.

The Indian Patent Office is administered by the Office of the Controller General of Patents, Designs and Trade Marks (CGPDTM) and it administers the Indian patent law. The Indian Patent Act (IPA) of 1970 consolidates the law relating to patents in India. The foreign filing license requirement is detailed in Section 39 of the IPA, as reproduced below.

39. Residents not to apply for patents outside India without prior permission.—
1) No person resident in India shall, except under the authority of a written permit sought in the manner prescribed and granted by or on behalf of the Controller , make or cause to be made any application outside India for the grant of a patent for an invention unless—
a) an application for a patent for the same invention has been made in India, not less than six weeks before the application outside India; and
b) either no direction has been given under sub-section (1) of section 35 in relation to the application in India, or all such directions have been revoked.
2) The Controller shall dispose of every such application within such period as may be prescribed:
Provided that if the invention is relevant for defense purpose or atomic energy, the Controller shall not grant permit without the prior consent of the Central Government.
3) This section shall not apply in relation to an invention for which an application for protection has first been filed in a country outside India by a person resident outside India.

35. Secrecy directions relating to inventions relevant for defense purposes.—
1) Where, in respect of an application made before or after the commencement of this Act for a patent, it appears to the Controller that the invention is one of a class notified to him by the Central Government as relevant for defense purposes, or, where otherwise the invention appears to him to be so relevant, he may give directions for prohibiting or restricting the publication of information with respect to the invention or the communication of such information.
2) Where the Controller gives any such directions as are referred to in subsection (1), he shall give notice of the application and of the directions to the Central Government, and the Central Government shall, upon receipt of such notice, consider whether the publication of the invention would be prejudicial to the defense of India, and if upon such consideration, it appears to it that the publication of the invention would not so prejudice, give notice to the Controller to that effect, who shall thereupon revoke the directions and notify the applicant accordingly.
3) Without prejudice to the provisions contained in sub-section (1), where the Central Government is of opinion that an invention in respect of which the Controller has not given any directions under sub-section (1), is relevant for defense purposes, it may at any time before grant of patent notify the Controller to that effect, and thereupon the provisions of that sub-section shall apply as if the invention where one of the class notified by the Central Government, and accordingly the Controller shall give notice to the Central Government of the directions issued by him.

Therefore, a foreign filing license is required if an Indian resident (either an Applicant, an inventor, or one inventor out of several inventors) wishes to file a patent application directly in a foreign country without first filing an application in India or if an international filing is filed within 6 weeks from the date of filing in India. However, if a patent application is filed in India, a foreign filing license is not needed if 6 weeks have passed since the Indian filing date.

In order to obtain a foreign filing license, permission is needed from the Controller (Controller General of Patents, Designs, and Trade Marks).

In order to request a foreign filing license from the Indian Patent Office, an Applicant must provide the following:
• “Form 25” titled “Request for Permission for making Patent Application outside India”
• The requisite fee
• A brief description of the invention covering the underlying inventive concept known to the Applicant at the time of making a request for the foreign filing license; The title of the invention and any related drawings should also be included
• The name(s), address(es), and nationalit(y/ies) of the inventor(s)/applicant(s) who are considered to be resident of India
• Names of co-inventors who are not resident of India
• The Power of Attorney from the inventor(s)/applicant(s) who are resident of India (mentioning their Indian addresses)
• Name, address, and nationality of any Assignee
• The country/countries in which the patent application is expected to be filed after obtaining the foreign filing license from the Indian Patent Office
• Reason for making such application (e.g. low market potential in India, non-patentable subject matter in India)

The Indian Patent Office generally acts on requests for foreign filing restrictions within 21 days from the date of filing the request, unless the invention relates to defense and atomic energy according to Rule 71, The Patent Rules, 2003, in which case the Controller shall not grant the foreign filing license without the prior consent of the Central Government.

(2) The time within which the Controller disposes of the request made under subrule (1), except in case of inventions relating to defence and atomic energy applications, shall ordinarily be within a period of twenty-one days from the date of filing of such request.

Who is subject to Indian Foreign Filing Restrictions?

The residential status of the applicant is relevant, while nationality and place of invention creation is not. Note that a foreign citizen can be a resident of India and an Indian citizen can be a resident of a foreign country.

Additionally, if there are joint inventors (and one or more of the inventors are Indian residents), then it is advisable to apply for a foreign filing license before filing the application.

The definition of “resident” of India is not defined in the IPA. Therefore, the meaning of resident can be interpreted from the Indian Tax Act of 1961 and the Foreign Exchange Maintenance Act of 1999, shown below:

According to Section 6 of the Income Tax Act of 1961, the term “resident” is defined as:
(1) An individual is said to be resident in India in any previous year, if he—
(a) is in India in that year for a period or periods amounting in all to one hundred and eighty-two days or more; or
(b) [Omitted]
(c) having within the four years preceding that year been in India for a period or periods amounting in all to three hundred and sixty-five days or more, is in India for a period or periods amounting in all to sixty days or more in that year.
[Explanation 1].—In the case of an individual,—
(a) being a citizen of India, who leaves India in any previous year as a member of the crew of an Indian ship as defined in clause (18) of section 3 of the Merchant Shipping Act, 1958 (44 of 1958), or for the purposes of employment outside India, the provisions of sub-clause (c) shall apply in relation to that year as if for the words “sixty days”, occurring therein, the words “one hundred and eighty-two days” had been substituted ;
(b) being a citizen of India, or a person of Indian origin within the meaning of Explanation to clause (e) of section 115C, who, being outside India, comes on a visit to India in any previous year, the provisions of sub-clause (c) shall apply in relation to that year as if for the words “sixty days”, occurring therein, the words “one hundred and eighty-two days” had been substituted.
[Explanation 2.—For the purposes of this clause, in the case of an individual, being a citizen of India and a member of the crew of a foreign bound ship leaving India, the period or periods of stay in India shall, in respect of such voyage, be determined in the manner and subject to such conditions as may be prescribed.]
(2) A Hindu undivided family, firm or other association of persons is said to be resident in India in any previous year in every case except where during that year the control and management of its affairs is situated wholly outside India.
(3) A company is said to be resident in India in any previous year, if—
(i) it is an Indian company ; or
(ii) during that year, the control and management of its affairs is situated wholly in India.
(4) Every other person is said to be resident in India in any previous year in every case, except where during that year the control and management of his affairs is situated wholly outside India.
(5) If a person is resident in India in a previous year relevant to an assessment year in respect of any source of income, he shall be deemed to be resident in India in the previous year relevant to the assessment year in respect of each of his other sources of income.
(6) A person is said to be “not ordinarily resident” in India in any previous year if such person is—
(a) an individual who has been a non-resident in India in nine out of the ten previous years preceding that year, or has during the seven previous years preceding that year been in India for a period of, or periods amounting in all to, seven hundred and twenty-nine days or less; or
(b) a Hindu undivided family whose manager has been a non-resident in India in nine out of the ten previous years preceding that year, or has during the seven previous years preceding that year been in India for a period of, or periods amounting in all to, seven hundred and twenty-nine days or less.

According to Section 2(v) of the Foreign Exchange Maintenance Act (FEMA) of 1999, the term “resident” is defined as:
(v) “person resident in India” means-
(i) a person residing in India for more than one hundred and eighty-two days during the course of the preceding financial year but does not include-
A. a person who has gone out of India or who stays outside India, in either case-
a. for or on taking up employment outside India, or
b. for carrying on outside India a business or vocation outside India, or
c. for any other purpose, in such circumstances as would indicate his intention to stay outside India for an uncertain period;
B. a person who has come to or stays in India, in either case, otherwise than-
a. for or on taking up employment in India, or
b. for carrying on in India a business or vocation in India, or
c. for any other purpose, in such circumstances as would indicate his intention to stay in India for an uncertain period;
(ii) any person or body corporate registered or incorporated in India,
(iii) an office, branch or agency in India owned or controlled by a person resident outside India,
(iv) an office, branch or agency outside India owned or controlled by a person resident in India;

Conversely, there is no indication in the IPA as to whether the Income Tax or FEMA definition of resident applies and there are no judicial precedents on this issue.

According to the Indian Income Tax Act, an individual is “resident” in India if he/she was in India for 182 days or more for the previous fiscal year (April 1-March 31) or was in India for a total of 365 days or more for the past 4 years, for a period or periods amounting in all to sixty days or more in that year. Note that if a person has handled the control and management of his affairs wholly outside of India, that person is not considered to be resident in India, even if he is an Indian national citizen.

If an inventor falls within the purview of any of the above definitions then he/she will need to obtain a foreign filing license before filing any international application.

Penalties

The penalties for failing to comply with Section 39 and obtain a foreign filing license before filing the application in a foreign country are the following:
• Imprisonment for up to 2 years
• Monetary fine
• Both imprisonment and fine
• Abandonment of any pending Indian Patent Application or revocation of an Indian Patent

40. Liability for contravention of section 35 or section 39

Without prejudice to the provisions contained in Chapter XX, if in respect of an application for a patent any person contravenes any direction as to secrecy given by the Controller under section 35, or makes or causes to be made an application for grant of a patent outside India in contravention of section 39 the application for patent under this Act shall be deemed to have been abandoned and the patent granted, if any, shall be liable to be revoked under section 64.

This post was written by Lisa Mueller and Himani Nadgauda of Michael Best and Nidhi Anand of Chadha & Chadha.

This is part 2 in our series examining foreign filing restrictions and licenses in the U.S. and in a number of countries throughout the world. To view part 1, foreign filing restrictions and licenses in the U.S., click here.

Foreign filing restrictions in China

A foreign filing license is always required in China. It is necessary as long as an invention or utility model is developed in China (inventions developed in Hong Kong, Macao and Taiwan are excluded), even if a domestic filing has been made first.

What constitutes “developed in China?” Rule 8 of the Implementing Regulations of the Patent Law (Implementing Regulations) provides some guidance. Specifically, according to this rule, an invention or utility model is considered to be “developed in China” if the “substantive contents” of the technical solution of the invention or utility model have been made or created by an inventor within China. The “substantive contents” of the technical solution can be determined based on the contents of the claims and identification of the inventors. According to Rule 13 of the Implementing Regulations, an “inventor” or “creator” is any person who makes “creative contributions” to the “substantive features” of the invention or creation. Inventors do not include those who solely provide organizational or auxiliary services or support.

According to Article 20.1 of Chinese Patent Law, the Chinese Patent Office (CPO, also known as State Intellectual Property Office of the People’s Republic of China, SIPO) must conduct a “Confidentiality Examination” of any invention or utility model developed in China in advance before an entity or individual files an application for a patent in a foreign country for the invention or utility model.

How is Confidentiality Examination requested?

There are three ways to request a Confidentiality Examination, depending on the type of patent application to be filed.

Method 1: Patent application intended to be filed abroad directly with no corresponding patent application to be filed at the CPO

An Applicant (such as an entity or individual filing a patent application) can file a request with the CPO, called a “Request for Confidentiality Examination of a Patent Application to be Filed Abroad,” and a description of the technical solution of the invention before filing a patent application with World Intellectual Property Office (WIPO) or in a foreign country. Both the request and the description of the technical solution must be in the Chinese language. Any corresponding documents, such as any patent applications to be filed abroad (which can be in their requisite foreign language), may also be submitted for the Examiner’s reference. The description of the technical solution must be identical with the contents of the documents (one or more patent applications) to be filed abroad.

If the technical solution does not need to be kept secret, then the Examiner is required to “promptly” notify the Applicant that the application can be filed abroad. If the technical solution needs to be kept secret, then the Examiner must inform the Applicant that the action of filing abroad will have to be suspended. If this is the result, the Examiner is required to conduct a further Confidentiality Examination.

The timeframe for the Confidentiality Examination is divided into two main parts. The first stage is a four month period, in which the Examiner conducts a preliminary review to determine if the invention is to remain confidential. The Examiner is required to issue a “Notification of Confidentiality Examination of Patent Application to be Filed Abroad” to the Applicant providing notification that further confidentiality review is needed. If such notification is not received within four months from the date of submitting the request, the Applicant can file a patent application for the technical solution in a foreign country. During the second stage of further confidentiality review, the review period will extend to six months from the date of submitting the original request. The Examiner is required to issue a “Decision on Confidentiality Examination of Patent Application to be Filed Abroad” based on the results of the further examination. If the Applicant does not receive this decision by the end of this six month review period, then the Applicant can file a patent application in a foreign country.

Practically speaking, it generally takes about two to four weeks from the date of request to receive a “Notification of Confidentiality Examination of Patent Application to be Filed Abroad.” Once this notification is received, the patent application can be filed in a foreign country. Additionally, under this method, no corresponding application is required to be filed in China.

Method 2: Patent application intended to be filed abroad at or after the corresponding Chinese patent application filed to the CPO

An Applicant can file a patent application in the CPO and request a Confidentiality Examination, at or after filing, prior to filing the application with WIPO or in a foreign country. As with the first case, the contents of the patent applications filed with the CPO and abroad must be identical and filed in the Chinese language. The four and six month periods for notification/decision apply under this procedure as well. Practically speaking, it generally takes about two to four weeks from the date of request to receive a “Notification of Confidentiality Examination of Patent Application to be Filed Abroad”. However, if a request for Confidentiality Examination is filed along with a patent application filing on the same day, the examination period may be shortened to two to five working days

Method 3: International application intended to be filed in the CPO through the Patent Cooperation Treaty (PCT)

An Applicant can file a Patent Cooperation Treaty (PCT) application in the CPO, with the CPO assuming the role as the Receiving Office. Such a request is considered to be a simultaneous request for Confidentiality Examination (a separate request for Confidentiality Examiner does not need to be filed). Under this procedure, at least one Applicant of the international application must have Chinese nationality or a residence in China. If the Applicant is not qualified to file the international application in the CPO, the CPO will forward the application documents directly to the International Bureau (IB), which is the Receiving Office for WIPO. Additionally, this procedure allows for the patent application to be submitted in either Chinese or English.

If the application does not need to be kept secret, then the Examiner handles the international application in accordance with typical PCT procedures. In other words, the CPO will issue a PCT/IB/304 form (“Notification Concerning Submission or Transmittal of Priority Document”) which indicates, among other things, that Confidentiality Examination has been completed. Once the Applicant receives the PCT/IB/304 form, it can file the patent application in a foreign patent office. Practically speaking it takes about four to six weeks to receive the PCT/IB/304 form (depending on how long it takes for the CPO to transmit the priority document to the International Bureau).

However, if the application needs to remain confidential, then the Examiner will issue a “Notification of Not Forwarding Record Copy and Search Copy for National Security Reasons” (Notification) within three months of the filing date. This Notification notifies the Applicant and the IB that the application will not be handled as an international application. The Notification also terminates the international phase and applicants are thereafter not permitted to file the patent application abroad.

Additional information regarding Confidentiality Examination

For each of the three methods of requesting Confidentiality Examination described above, if a patent application relates to the interests concerning national defense and is required to by kept secret, the application is sent to the National Defense Patent Office, which carries out the examination.

If it is believed that a patent application relates to security and other vital interests of China and should be kept secret, an Applicant should indicate such at the time of the filing of the application. In this instance, the patent application should be submitted in paper form (not via the electronic filing system). Additionally, an Applicant can also request that a patent application be kept secret before it is publically disclosed by the CPO.

If a patent application is filed electronically and the CPO determines that it must be kept secret (because the invention relates to the security or other vital interests of the country), examination will be conducted on paper and not using the electronic filing system.

There is no official fee for solely requesting a Confidentiality Examination. Approximately 99.9% of the cases received by the CPO have passed the Confidentiality Examination process and have been permitted to be filed in foreign countries.

The CPO conducts a review on the patent applications/patents to be kept secret every two years and is required to notify an Applicant of declassification of any applications/patents that are no longer required to be kept secret.

Processing after Declassification

When and if a patent application becomes declassified, it is examined and administered as a regular patent application for invention. When and if a granted patent becomes declassified, the decision on its declassification is announced and it is published and administered as a regular patent.

Penalty

If a foreign filing license is not requested and the patent application is filed abroad, then a patent for the invention will not be granted in China. If the patent application is related to security or other vital state interests, then criminal penalties will result for the Applicant.

Strategic Considerations

Multinational corporations employing global research teams as a part of their research and development must carefully consider their patent application filing strategy for any inventions created and/or developed in China. Some items that should be considered include:

1. Allow yourself as much time as possible to draft your application (especially if you are aware of any impending statutory deadlines). Carefully consider all elements and features of the invention, any potential commercial products and your claiming strategy. For example, if only chemical intermediates were synthesized in China, consider whether or not your claims encompass such intermediates. If you are not claiming intermediates (and your claims do not broadly encompass any such intermediates), the invention may not be considered to have been developed in China and no request for Confidentiality Examination is required. Also allow yourself as much time as possible if, within a year after filing your patent application in China, you intend to add additional information and/or subject matter to your originally filed application.

2. Do a complete and thorough inventorship analysis.

3. Consider whether or not one or more foreign filing licenses will be required from another jurisdiction prior to filing in China. If your application also contains inventors from the U.S., India, Russia, etc., a request for a foreign filing license will be required prior to filing in China.

4. Consider filing a Chinese patent application along with a request for Confidentiality Examination, without paying the official fees for the Chinese patent application. Using this strategy, the period for Confidentiality Examination will be shortened to two to five working days. Because the official fees have not been paid, the Chinese patent application will be deemed as withdrawn and will not be published.

This post was written by Lisa Mueller and Himani Nadgauda of Michael Best and Aaron D. Hurvitz of Kangxin Partners, P.C.

This is part 1 in our series examining foreign filing restrictions and licenses in the U.S. and in a number of countries throughout the world. Some of the countries we will examine include: Argentina, Australia, Austria, Belgium, Canada, Chile, China, Columbia, Czech Republic, Denmark, Finland, France, Germany, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Liechtenstein, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Peru, Philippines, Portugal, Russia, Singapore, Slovak Republic, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Venezuela and Vietnam.

What are foreign filing restrictions and licenses?

Many governments require approval before technology described in a patent application can be exported abroad, especially if a patent filing is not first being made in the country of invention. In many countries, this approval is given in the form of a foreign filing license, which must be granted by the appropriate government agency before a patent application can be filed abroad. The foreign filing license requirement is in place to protect national security. In fact, patent applications denied a foreign filing license are often directed to sensitive technologies that a defense agency or government deems important for military purposes and/or potentially detrimental to the safety of the country if exported. Examples of such technology include explosives, nuclear technology, atomic energy materials and biological warfare materials.

Law governing foreign filing licenses in the U.S.

According to 35 U.S.C. Section 184 (Section 184), a foreign filing license is required for a patent application if the claimed subject matter was made in the U.S. and (1) it has been less than 6 months after an application was first filed in the U.S., or (2) no application has yet been filed in the U.S. Specifically, Section 184 reads as follows:

35 U.S.C. Section 184 – filing of applications in foreign countries

Except when authorized by a license obtained from the Commissioner of Patents a person shall not file or cause or authorize to be filed in any foreign country prior to six months after filing in the United States an application* for patent or for the registration of a utility model, industrial design, or model in respect of an invention made in this country.

*Application is defined as including not only the application itself but any modifications, amendments, or supplements thereto, or divisions thereof

Thus, in order to obtain legal permission to file a patent application claiming an invention made in the U.S., a petition for a foreign filing license must be granted or a minimum of 6 months must have passed after the application was filed in the U.S. Patent and Trademark Office (U.S. PTO), provided no secrecy order has been imposed. Without such a license, a person is not permitted to file, cannot cause to be filed, or authorize a patent application to be filed in another country unless the 6 month period from the filing has elapsed.

Obtaining a foreign filing license in the U.S.

Every U.S. origin application filed in the U.S. PTO is considered to include an implicit petition for a foreign filing license. The filing receipt of the application will indicate if the foreign filing license is granted. Generally, the filing receipt will recite: “If Required, Foreign Filing License Granted” followed by a date. The license is effective on the date shown on the receipt.

Explicit and expedited foreign filing licenses must be requested under the following circumstances:

The filing of a corresponding foreign patent application is desired on the same day or within a few days of the filing of a first U.S. application (as either a provisional or nonprovisional), where the U.S. application has not been granted a foreign filing license.

The patent application includes subject matter invented in the U.S. that will be filed first in a foreign patent office with no corresponding U.S. application.

New subject matter invented in the U.S. will be added to an existing and licensed U.S. patent application that will first be filed in a foreign patent office.

A foreign filing license for foreign patent application associated with a first-filed U.S. provisional or non-provisional patent application is desired on an expedited basis.

A foreign filing license has not been granted on a filing receipt, and it is less than 6 months after the filing date of an application.

Petition for an expedited foreign filing license

An expedited foreign filing license can be obtained by filing a petition with the U.S. PTO. While there is no required format for the petition, the U.S. PTO prefers that the petition be provided in letter form. The petition must include: the U.S. application number (if known), filing date (if known), inventor, the required fee (the fee for an expedited foreign filing license is provided in 37 C.F.R. 1.17(g) (currently, $200.00)), as well as the contact information for the delivery of the requested license (generally fax or mail). A copy of the material for which a license is desired (typically, a copy of the patent application to be filed abroad) should also be provided, particularly if no corresponding national/international design or international application has been filed.

Applicants are encouraged to hand deliver or fax (571-273-0185) the license request directly to the Licensing and Review department of the U.S. PTO. The license becomes valid when the petition is granted, which generally occurs within 3 business days from its receipt, provided that the subject matter contained in the application does not present any security issues. The scope of the license granted by petition is indicated on the license.

Once obtained, a foreign filing license gives the holder the right to file and prosecute a patent application in a foreign patent agency or international patent agency. It allows the holder to make changes to the foreign patent application in the form of modifications, amendments, and divisionals as long as they do not change the general nature of the invention (Section 184(c)). The license also authorizes the export of technical data related to prosecution of the foreign application.

Petition for a retroactive foreign filing license

If an expedited foreign filing license is not requested prior to the filing of an application abroad, an Applicant can submit a petition to the U.S. PTO requesting a retroactive foreign filing license (pursuant to 37 CFR Section 5.25) provided that the Applicant can demonstrate that the unlicensed foreign filing occurred as a result of an error. Such a petition must include a list of each of the foreign countries in which the unlicensed patent application material was filed and the corresponding filing dates. The petition must also include a verified oath or declaration describing the nature of the error that specifically includes a statement that the subject matter in question was not under a secrecy order at the time it was filed abroad nor is it currently under such an order. The oath/declaration must (1) show that the license had been diligently sought after discovery of the proscribed foreign filing and (2) include an explanation of why the material was filed abroad through error without the required license having been obtained. Additionally, the petition should also include the required fee (the fee for a petition for a retroactive foreign filing license is provided in 37 C.F.R. 1.17(g) (currently, $200.00)). The petition should explain Applicant’s standard operating procedure (SOP) for obtaining an expedited foreign filing license and explain why any such SOP was not followed for the filing in which a retroactive foreign filing license is sought. Petitions are granted or denied by the Office of Petitions; such decisions can sometimes take several months.

Penalties

If a foreign filing license is not obtained, the corresponding U.S. application will not be granted, and if the patent has been issued, will be considered to be invalid. The Applicant can also be fined up to $10,000 and face imprisonment of up to 2 years.

Revocation of a foreign filing license

On the rare occasion, a foreign filing license can be revoked after issuance by the U.S. PTO. This occurs if the U.S. PTO has conducted additional review of the licensed subject matter and decided to refer the application to the appropriate defense agencies. Any subsequent revocation of a foreign filing license becomes effective on the date on which the notice is mailed. Any foreign filings that have occurred prior to the revocation do not need to be abandoned or otherwise specially treated. However, no additional filings without a license are permitted unless 6 months have elapsed from the filing of the corresponding U.S. application.

According to reports, the Indian Ministry of Health is planning on releasing revised guidelines on the approval of “similar biologics” sometime in February/March 2016. India’s biosimilar guidelines became effective on September 15, 2012. It is believed that the revised guidelines will address a host of items including increased requirements regarding comparability testing with a reference drug product, as well as various ethical questions.

U.S. FDA Approves a “Similar” but not a “Biosimilar” version of Lantus®

On December 16, 2015, the U.S. Food and Drug Administration (FDA) announced that it had approved Eli Lilly/Boehringer Ingelheim’s (Lilly) Basaglar® product as the first “follow-on” insulin glargine product for use in improving glycemic control in adult and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. Basaglar® is the first insulin product approved through an abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act. Specifically, Lilly submitted a 505(b)(2) application for Basaglar® that relied, in part, on the FDA’s finding of safety and effectiveness of Sanofi’s Lantus® for its approval. While similar to Lantus®, Basaglr® was not approved as a biosimilar. In contrast, in Europe, on September 9, 2014, the European Medicines Agency approved Lilly’s product as a biosimilar under the brand name Abasaglar (originally approved under the brand name Abasria).

While Basaglar® received tentative approval from the FDA in August 2014, a 30-month hold was placed on its market entry because of a patent infringement dispute with Sanofi which was settled in September 2015.